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Pramoxine Hydrochloride

Class: Antipruritics and Local Anesthetics
ATC Class: D04AB07
VA Class: DE700
CAS Number: 637-58-1
Brands: Analpram, Analpram HC, Blistex Pro Relief, Caladryl, Campho-Phenique Cold Sore, Fleet Pain-Relief, Hemorid, Itch-X, Neosporin, Neosporin LT, Neosporin + Pain Relief, PrameGel, Pramosone, Prax, Preparation H, proctofoam, proctofoam-HC, Tronolane, Tucks, Vagisil Medicated

Introduction

Local anesthetic.101 105 106 107

Uses for Pramoxine Hydrochloride

Dermatologic Conditions

Self-medication for the temporary relief of pain and itching associated with minor lip or skin irritations (e.g., dermatoses, insect bites, minor burns or sunburns, minor cuts or scrapes, cold sores, hives, rashes due to poison ivy, poison oak, or poison sumac).100 102 103 108 109 110 b f k j

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Anorectal/Anogenital Disorders

Self-medication for the temporary relief of pain, soreness, burning, itching, or discomfort associated with hemorrhoids and other anorectal or anogenital disorders (e.g., inflammation, irritation, fissures, anogenital pruritus).101 104 105 106 107 111 c d e g

In fixed combination with hydrocortisone for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.i

Pramoxine Hydrochloride Dosage and Administration

Administration

Topical

Apply topically to the skin as a gel, lotion, ointment, or solution.100 102 103 110 b f

Apply topically to the lip as an ointment.108 109 k

Do not use topical skin preparations for vaginal, genital, or rectal itching.100 b

For external use only; avoid contact with the eyes and nose.100 101 102 103 104 105 106 107 108 109 110 111 b c f Do not apply to extensive areas of skin, open wounds, or damaged or blistered skin; do not use for prolonged periods.100 102 b

Do not use on deep or puncture wounds, animal bites, or serious burns.108 109

Apply to cold sores and fever blisters after blister has dried.k

Shake lotion well before use.102 103 107 f j

Anorectal Topical Administration

Apply externally to the anorectal area as an aerosol foam, cream, ointment, lotion, or pledgets.101 104 105 106 107 c d e Do not insert drug into rectum using fingers or any mechanical device.104 105 106 107 c d e

Before applying drug, cleanse the affected perianal area with mild soap and warm water and rinse thoroughly whenever practical; dry by patting or blotting with toilet tissue or a soft cloth.101 104 105 106 107 c d e

Shake aerosol foam before use.i Disperse onto a clean tissue before applying to the affected area.107 i Rub in gently.i Do not insert any part of the aerosol container past anus into the rectum.107 i Clean applicator thoroughly after each use.i

Apply pledget by gently patting the affected area with pledget; use pledget only once, then discard.101 c

Vaginal Topical Administration

Apply externally to vaginal area as vaginal pledgets.111 g

Apply by gently patting or wiping the affected area from front to back;g use pledget only once, then discard.111 g

Anal Administration

Apply topically to anus as an aerosol foam.i

In fixed combination with hydrocortisone: Apply aerosol foam using provided applicator for anal administration.i

Shake aerosol foam before use.i Do not insert any part of the aerosol container past anus into the rectum.107 i Clean applicator thoroughly after each use.i

Dosage

Available as pramoxine hydrochloride; dosage expressed in terms of the salt.a

Pediatric Patients

Dermatologic Conditions
Topical

Children ≥2 years of age (self-medication): Apply gel, lotion, ointment, or solution to the affected area up to 3 or 4 times daily.100 102 103 108 109 110 b f k

Fixed combination with hydrocortisone: Apply cream, lotion, or ointment to the affected area as a thin film 3 or 4 times daily.j Administer the least amount of topical preparations that provides effective therapy.j (See Pediatric Use under Cautions.)

Anorectal/Anogenital Disorders
External Anorectal Topical

Children ≥12 years of age (self-medication): Apply cream, foam, ointment, or pledget to the affected area up to 4 or 5 times daily or after each bowel movement.101 104 105 106 107 c d e

External Vaginal Topical

Children ≥12 years of age (self-medication): Apply as pledget to the affected area up to 3 or 4 times daily.111 g

Anal Topical

Fixed combination with hydrocortisone: Apply foam to the affected area 3 or 4 times daily.i (See Pediatric Use under Cautions.)

Adults

Dermatologic Conditions
Topical

As self-medication: Apply gel, lotion, ointment, or solution to the affected area up to 3 or 4 times daily.100 102 103 108 109 110 f k

Fixed combination with hydrocortisone: Apply cream, lotion, or ointment to the affected area as a thin film 3 or 4 times daily.j

Anorectal/Anogenital Disorders
External Anorectal Topical As (self-medication)

Apply cream, foam, ointment, or pledget to the affected area up to 4 or 5 times daily or after each bowel movement.101 104 105 106 107 c d e

External Vaginal Topical As (self-medication)

Apply as pledget to the affected area up to 3 or 4 times daily.111 g

Anal Topical

Fixed combination with hydrocortisone: Apply foam to the affected area 3 or 4 times daily.i

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

Careful dosage selection recommended due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy; use lowest effective dosage.i

Cautions for Pramoxine Hydrochloride

Contraindications

  • Known hypersensitivity to pramoxine or any ingredient in the formulation.a i j

Warnings/Precautions

Warnings

Administration Precautions

For external use only.100 101 102 103 104 105 106 107 108 109 110 111 b c d e f k Avoid contact with the eyes and nose.100 102 103 108 109 110 111 b f i k

Do not use topical skin preparations (intended for skin irritation) for vaginal, genital, or rectal itching.100 b

Do not apply to extensive areas of skin, open wounds, or damaged/blistered skin.100 102 b

Do not use for prolonged periods.100 102

Do not use on deep or puncture wounds, animal bites, or serious burns.108 109 b

Do not insert the drug preparation into the rectum using fingers or any mechanical device.104 105 106 107 c d e Do not insert any part of an aerosol container into the rectum.107 i

Discontinue and consult a clinician if erythema, irritation, swelling, pain, or other symptoms develop or worsen during therapy, or if pain or itching persists for >7 days, worsens, or resolves and occurs again within a few days, or if rectal bleeding occurs during use.100 101 102 103 104 105 106 107 108 109 110 111 c d e f k

Discontinue use of fixed-combination pramoxine and hydrocortisone aerosol foam if condition worsens or does not improve in 2–3 weeks.i

Sensitivity Reactions

Hypersensitivity Reactions

Allergic reactions may occur.101 106 107 c d e

If allergic reaction occurs, discontinue the drug and consult a clinician.104 105 d e

Cross-sensitivity

Low index of sensitization; cross-sensitization with other local anesthetics is unlikely.a

General Precautions

Use of Fixed Combinations

When used in fixed combinations with allantoin, calamine, dimethicone, hydrocortisone acetate, neomycin, phenylephrine hydrochloride, polymyxin B, or zinc oxide, consider the cautions, precautions, and contraindications associated with the concomitant agent.

Specific Populations

Pregnancy

Category C.h

Lactation

Not known whether topical pramoxine is distributed into milk.h

Pediatric Use

Safety and efficacy of topical gel, lotion, ointment, or solution not established in children <2 years of age.100 102 103 108 109 110 b f k

Safety and efficacy of topical vaginal pledgets, anorectal cream, foam, ointment, or pledgets not established in children <12 years of age.101 104 106 107 c d e g

Fixed-combination preparations containing hydrocortisone: Limit topical therapy in children to the minimum amount necessary for therapeutic efficacy.i j

Common Adverse Effects

Local burning or stinging.a

Pramoxine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed following topical application.h

Distribution

Extent

Not known whether pramoxine crosses the placenta or is distributed into milk.h

Stability

Storage

Topical

Aerosol

Upright at 20–25°C; i do not refrigerate.107 i Do not puncture, burn, or expose to temperatures >49°C.107 i

Cream

Tight container at 15–30°C.100 103 104 105 j

Lotion

15–25°C.f

Ointment

Tight container at 15–30°C;e j some preparations 20–25°C.d

Actions

  • Structurally similar to dyclonine; does not contain the usual ester or amide linkage of the procaine-type drugs.a

  • Stabilizes neuronal membrane of nerve endings with which it comes into contact.j

  • Temporarily forms a protective coating over inflamed tissues to help prevent drying.c d

  • Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.f

Advice to Patients

  • For external use only; avoid contact with the eyes and nose.100 101 102 103 104 105 106 107 108 109 110 111 b c d e f i k

  • Importance of not using topical skin preparations for vaginal, rectal, or genital itching.100 b

  • Importance of using as directed; importance of not applying to extensive areas of skin, open wounds, or damaged or blistered skin; importance of not using for prolonged periods.100 102 b

  • Importance of discontinuing therapy and consulting clinician if dermatologic condition worsens, if symptoms persist for >7 days or clear and occur again within a few days, if rash or irritation develops during therapy, or if rectal bleeding occurs.100 101 102 103 104 105 106 107 108 109 110 111 c d e f k

  • Importance of discontinuing therapy and consulting clinician if condition worsens or if there is no evidence of improvement after 2–3 weeks of using aerosol foam containing pramoxine in fixed combination with hydrocortisone. i

  • Importance of not inserting the drug preparation into the rectum using fingers or any mechanical device including any part of an aerosol container.104 105 106 107 c d e

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.100 105 106 107 e

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription OTC drugs as well as any concomitant illnesses.a e

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Pramoxine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Aerosol, foam suspension

1%*

proctofoam

Schwarz

Pramoxine Hydrochloride Foam

Cream

1%

Hemorrhoidal Anesthetic Cream

Clay-Park

Gel

1%

Itch-X

Ascher

PrameGel

Doak

Lotion

1%

Prax Lotion

Ferndale

Ointment

1%

Campho-Phenique Cold Sore Treatment for Scab Relief

Bayer

Pledgets (saturated with solution)

1%

Fleet Pain-Relief Pads

Fleet

Vagisil Anti-itch Medicated Wipes

Combe

Solution

1%

Itch-X Spray

Ascher

Pramoxine Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Aerosol, foam suspension

1% with Hydrocortisone Acetate 1%

proctofoam-HC

Schwarz

Cream

1% with Hydrocortisone Acetate 1%

Analpram HC

Ferndale

Pramosone

Ferndale

1% with Hydrocortisone Acetate 2.5%

Analpram HC

Ferndale

Pramosone

Ferndale

Preparation H Maximum Strength

Wyeth

1% with Neomycin 0.35% and Polymyxin B 10,000 units/g

Neosporin + Pain Relief

Pfizer

1% with Phenylephrine Hydrochloride 0.25%

Hemorid Creme

McNeil

1% with Zinc Oxide 5%

Tronolane

Monticello

Lotion

1% with Calamine 8%

Caladryl Lotion

McNeil

1% with Hydrocortisone Acetate 1%

Pramosone

Ferndale

1% with Hydrocortisone Acetate 2.5%

Analpram HC

Ferndale

Pramosone

Ferndale

1% with Zinc Acetate 0.1%

Caladryl Clear

McNeil

Ointment

1% with Allantoin 1.5%

Neosporin LT Lip Treatment

Blistex

1% with Dimethicone 2%

Blistex Pro Relief

Blistex

1% with Hydrocortisone Acetate 1%

Pramosone

Ferndale

1% with Hydrocortisone Acetate 2.5%

Pramosone

Ferndale

1% with Neomycin 0.35% and Polymyxin B 10,000 units/g

Neosporin + Pain Relief

Pfizer

1% with Phenylephrine Hydrochloride 0.25%

Hemorid

McNeil

1% with Zinc Oxide 12.5%

Tucks Hemorrhoidal

McNeil

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Analpram-HC 1-2.5% Cream (FERNDALE LAB): 30/$118.33 or 90/$337.86

Analpram-HC 1-2.5% Lotion (FERNDALE LAB): 59/$116.04 or 177/$324.04

Analpram-HC Singles 1-2.5% Cream (FERNDALE LAB): 120/$232.54 or 360/$654.05

Hydrocortisone Ace-Pramoxine 1-1% Cream (PERRIGO PHARMACEUTICALS): 30/$79.99 or 90/$219.98

Hydrocortisone Ace-Pramoxine 2.5-1% Cream (ACELLA PHARMACEUTICALS): 28/$49.99 or 85/$139.97

Hydrocortisone Ace-Pramoxine 2.5-1% Cream (PERRIGO PHARMACEUTICALS): 30/$51.99 or 90/$145.97

Pramosone 1-1% Cream (FERNDALE LAB): 28/$95.33 or 85/$245.45

Pramosone 1-1% Lotion (FERNDALE LAB): 59/$98.90 or 118/$183.98

Pramosone 1-1% Ointment (FERNDALE LAB): 28/$92.05 or 85/$248.37

Pramosone 1-2.5% Cream (FERNDALE LAB): 28/$89.82 or 57/$172.74

Pramosone 1-2.5% Cream (FERNDALE LAB): 57/$117.27 or 171/$346.20

Pramosone 1-2.5% Lotion (FERNDALE LAB): 118/$170.46 or 354/$496.34

Proctofoam 1% Foam (ALAVEN PHARMACEUTICAL): 15/$45.13 or 45/$133.20

Proctofoam HC 1-1% Foam (MEDA PHARMACEUTICALS): 10/$79.99 or 30/$219.96

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions April 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. B.F. Ascher & Co., Inc. Itch-X gel/spray product information. Lenexa, KS; undated.

101. Fleet. Fleet pain-relief pads product information. From the drugstore.com website (). Accessed 2005 Jan 6.

102. Ferndale Laboratories, Inc. Prax lotion product information. Ferndale, MI; undated.

103. Pfizer consumer healthcare. Caladryl clear lotion product information. In: Physicians’ desk reference. From the Drugs.com website (). Accessed 2005 Jan 6.

104. Pfizer consumer healthcare. Anusol hemorrhoidal ointment product information. Morris Plains, NJ; undated.

105. Pfizer consumer healthcare. Hemorid hemorrhoidal ointment product information. Morris Plains, NJ; 2001.

106. Monticello Companies, Inc. Tronolane hemorrhoidal cream product information. Jacksonville, FL; undated.

107. Schwarz Pharma. Proctofoam non-steroidal hemorrhoidal foam product information. Milwaukee, WI; undated.

108. Blistex Inc. Blistex Pro Relief lip balm product information. Oak Brook, IL; undated.

109. Pfizer consumer healthcare. Neosporin LT lip treatment product information. Morris Plains, NJ; undated.

110. Bayer consumer care. Campho-Phenique cold sore treatment with scab relief product information. Morristown, NJ; undated.

111. Combe Inc. Vagisil anti-itch medicated wipes product information. White Plains, NY; undated.

a. AHFS drug information 2007. McEvoy GK, ed. Pramoxine hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3539-40.

b. B.F. Ascher & Co., Inc. Itch-X gel patient information. Lenexa, KS; undated. Available at: . Accessed 2007 Dec 31.

c. C.B. Fleet Co., Inc. Fleet pain-relief pre-moistened anorectal pads patient information. Lynchberg, VA; undated. Available at: . Accessed 2007 Dec 31.

d. McNeil-PPC, Inc. Tucks hemorrhoidal ointment patient information. Morris Plains, NJ; undated. Available at: . Accessed 2007 Oct 12.

e. McNeil-PPC, Inc. Hemorid ointment patient information. Morris Plains, NJ; undated. Available at: . Accessed 2007 Dec 31.

f. McNeil-PPC, Inc. Caladryl clear lotion patient information. Morris Plains, NJ; undated. Available at: . Accessed 2007 Dec 31.

g. Combe Inc. Vagisil anti-itch medicated wipes patient information. White Plains, NY; undated. Available at: . Accessed 2007 Dec 31.

h. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Phildelphia, PA: Lippincott Williams & Wilkins; 2005:1330-1.

i. Proctofoam-HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol prescribing information. In PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2006. Updated 2004 Aug.

j. Ferndale Laboratories Inc. Pramosone (hydrocortisone acetate and promoxine hydrochloride) cream, lotion, and ointment prescribing information. In PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2006. Updated 2005 May.

k. Bayer HealthCare LLC. Campho-phenique (pramoxine HCl 1% and white petrolatum 30%) cold sore treatment for scab relief patient information. 2007; Available at: . Accessed 2007 Dec 31.

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